Uveitis
Conditions
Keywords
Humira®, Adalimumab, Ocular inflammation, Active non-infectious intermediate, posterior and panuveitis
Brief summary
This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including effect on ocular inflammation, health-related quality of life, health resource utilization, work ability and medication burden, as well as describe the characteristics of NIIPPU participants treated with Humira® in the real-life setting.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Participants voluntarily signed a patient authorization form to use and disclose personal health information (or informed consent, where applicable). * Age \>= 18 years at the time of the enrollment. * Diagnosis of active NIIPP uveitis as defined by the presence of at least 1 of the following parameters: 1. Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion 2. \>= 2+ anterior chamber cells \[Standardization of Uveitis Nomenclature (SUN) criteria\] 3. \>= 2+ vitreous haze \[National Eye Institute (NEI)/SUN criteria\] * Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines. * Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study.
Exclusion criteria
* Participants who cannot be treated with Humira® according to the local Humira® SmPC and/or local professional and reimbursement guidelines. * Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments. * Participants currently participating in other clinical research. * Participants who are unwilling or unable to complete the quality of life and other patient reported questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who achieve treatment response at any of the follow-up visits | Up to Month 12 | Definition of response: quiescence defined as patients with no new active chorioretinal inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of \<=0.5+ in both eyes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in intraocular pressure | From Month 1 to Month 12 | Assessing change from baseline in intraocular pressure |
| Percent Change in Total work productivity impairment | Up to Month 12 | Assessing Percent Change in Total work productivity impairment |
| Change in outpatient visits | From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months) | Assessing change in outpatient visits |
| Proportion of participants with maintained response at any of follow up visits | Up to Month 12 | Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit. |
| Percent change in Presenteeism | Up to Month 12 | Assessing percent change in presenteeism |
| Proportion of participants with maintained response separately for each follow-up visit | Up to Month 12 | Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit. |
| Percent Change in Total activity impairment | Up to Month 12 | Assessing Percent Change in Total activity impairment |
| Change in hospitalization days prior to and during Humira® treatment | From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months) | Assessing change in hospitalization days prior to and during Humira® treatment |
| Change in emergency room admissions | From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months) | Assessing change in emergency room admissions |
| Proportion of participants with treatment response separately for each follow-up visit | Up to Month 12 | Response is defined as participants with no new active inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of \<=0.5+ in both eyes. |
| Change from baseline in Best corrected visual acuity (BCVA) | From Month 1 to Month 12 | Assessing change from baseline in Best corrected visual acuity (BCVA) |
| Change in cumulative hospital admissions | From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months) | Assessing change in cumulative hospital admissions |
| Change from baseline in Central Retinal Thickness (CRT) | From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months) | Assessing change from baseline in Central Retinal Thickness (CRT) |
| Proportion of participants with flare at any of follow up visit | Up to Month 12 | Flare is defined as new active inflammatory lesions or AC cell grade of \>=2+ or VH grade of \>=2+ at least in one eye. |
| Percent change in Absenteeism | Up to Month 12 | Assessing percent change in absenteeism |
| Changes in total score of Work Productivity & Activity Impairment (WPAI)-UV score | From Month 1 to Month 12 | Assessing changes in total score of WPAI-UV score |
Countries
Austria, Colombia, Czechia, Germany, Greece, Hungary, Ireland, Israel, Kuwait, Lebanon, Switzerland, United Arab Emirates
Outcome results
None listed